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Diabetic Macular Edema
According to the National Eye Institute (NEI), diabetic retinopathy is the most prominent complication of diabetes and the leading cause of blindness in working age individuals. NEI estimates that ~9 million Americans are living with diabetic retinopathy and predicts the incidence will double over the next 15 years.
In diabetic retinopathy, the small blood vessels that feed the back of the eye, known as the retina, degenerate and re-grow in an abnormal manner. These diseased blood vessels block light and can leave scars in the retina, leading to vision loss. Diabetic macular edema (DME) is a common complication of diabetic retinopathy and the leading cause of blindness in adults with diabetes.
During the course of diabetes, prolonged hyperglycemia induces cellular senescence. These senescent vascular cells compromise the integrity of the blood vessels in the retina and release inflammatory factors that collectively compromise healthy vasculature. In DME, the damaged blood vessels leak into the retina, resulting in the accumulation of fluid in the macula – or the central part of the retina. Over time, the macula swells and may lead to severe vision loss.
Anti-VEGF Therapies in DME
Anti-VEGF therapies are the current standard of care for DME and work by blocking the growth of new blood vessels to limit the amount of fluid accumulation in diabetic eyes. In contrast to senolytic therapies however, anti-VEGF therapies halt the production of all blood vessels – both healthy and diseased ones.
Treatment Burden and Unmet Need
One of the limitations of the current standard of care, anti-VEGF therapy, for retinal diseases is that they target both sick and healthy parts of the eye. Anti-VEGF agents can potentially impair normal remodeling of healthy vessels and block all blood vessel growth.
With currently available anti-VEGF treatments, 3-5 monthly loading doses followed by every 8-week dosing is required, imposing a tremendous treatment burden on patients. In real-world use, this treatment regimen is unsustainable. In addition, many people with DME have poor vision despite frequent anti-VEGF injections and experience sub-optimal benefits, however there are few alternatives on the market.
UBX1325 represents a new potential class of neovascular treatments that provide a viable and much needed alternative to current treatment modalities.
By selectively eliminating senescent cells in the retina, senolytic therapies are an entirely new approach to potentially reduce a key source of inflammation, allow healthy cells to regenerate and enable the retina to repair itself, thus promoting healthy revascularization in the eye and leading to long-term disease modification.
As a distinct mechanism of action to anti-VEGF agents, senolytic therapies not only have the potential to address the limitation of but also complement anti-VEGF treatments.
Clinical Trials
Ongoing
UNITY is currently conducting the ASPIRE Phase 2b Study for people with DME who are not achieving optimal benefit from anti-VEGF drugs. The ASPIRE Study is evaluating the safety and efficacy of multiple doses of UBX1325 in patients with diabetic macular edema. (NCT06011798)
For potential participants or physicians interested in learning more about the studies, please visit clinicaltrials.gov.
Clinical Trial Access
Thank you for your interest in UNITY Biotechnology. UNITY is committed to ensuring the safety of the patients and volunteers who take part in our clinical trials and to upholding the highest ethical, scientific, and clinical standards in all of our research initiatives.
UNITY sponsored clinical trials are designed and conducted in accordance with applicable laws and regulations, as well as recognized medical and ethical standards so that the health, well-being, and safety of research participants are protected.
More information about UNITY clinical trials that are currently open for enrollment can be found here.
If you are a patient or an investigator interested in one of our clinical trials, please contact us.